Light Stimulation to Improve Visual Function After Optic Neuritis in Persons With Multiple Sclerosis (ONSTIM)

Lichtstimulation Zur Verbesserung Der Sehleistung Bei Patientinnen Und Patienten Mit Multipler Sklerose Nach Sehnerventzündung

The aim of this monocentric randomized controlled intervention study is to improve visual function in persons with multiple sclerosis following optic neuritis (neuritis nervi optici) by means of a light stimulation.

In the treatment arm, two 80-second light stimulations are to be administered daily for 12 days in 25 persons with multiple sclerosis following recent optic neuritis (1-3 months). For the standardized application of light stimulation in the sense of standardized training, the light stimulation is to be carried out by watching a generated flicker video on a mobile phone. In a sham-intervened control group (sample size 25), the spontaneous course after optic neuritis will be recorded in parallel. Intensive neuronal stimulation of the visual pathway will be used to stimulate regenerative processes, which will be recorded by means of changes in high-contrast visual acuity (primary endpoint). Secondary endpoints are changes in a colored-contrast test, in 2.5% low contrast visual acuity, the peak conduction latency of visual evoked potentials, and retinal layer thicknesses and vessel densities measured in optical coherence tomography and optical coherence tomorgraphic angiography. These physiological parameters should help to understand the underlying processes of a potentially altered visual performance.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis, Relapsing-Remitting; Optic Neuritis
• Intervention / Treatment: Device: Light stimulation; Device: Sham light stimulation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Relapsing remitting multiple sclerosis or clinically isolated syndrome or no indication of chronic inflammatory central nervous system disease
• Age 18-60 years
• Optic neuritis within 1-3 months

Exclusion Criteria:

• Epilepsy
• Light-triggered migraine
• Insufficient vision correction
• Retinal disease (glaucoma, macular edema, macula degeneration, ...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Light stimulation; Experimental light stimulation (3 colors at 20 Hertz each for 80 seconds twice a day).	Device: Light stimulation; see arm description
Sham Comparator: Sham light stimulation; Sham light stimulation (white screen for 80 seconds twice a day).	Device: Sham light stimulation; see arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High contrast visual sensitivity	Visual resolution with Sloan chart	before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low contrast visual sensitivity	Sloan chart at 2.5%	before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Visually evoked potentials	Visually evoked potential	before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Optical coherence tomography	Optical coherence tomography	before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Optical coherence tomographic angiography	Optical coherence tomographic angiography	before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)
Color contrast	Color contrast threshold (3 colors)	before intervention, directly after the first stimulation, after 12 days of training (stimulation) as 24 hour retention, and at 22 days post-intervention (retention)

Collaborators and Investigators

• Sponsor: Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Neuritis; Optic Neuritis
• Other Study ID Numbers: 2023-491-S-KH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No